other material
confidence high
sentiment negative
materiality 0.70
Cerus gets $248M BARDA contract for RBC program; EU CE Mark review denied
CERUS CORP
- New BARDA contract valued up to $248M to support U.S. INTERCEPT RBC system development and PMA submission; $32.1M awarded for base period.
- CE Mark review in Europe closed without approval due to insufficient impurity profile data; company assessing strategy for future filing.
- RedeS Phase 3 trial enrolling at two new sites; timing of completion and PMA submission under assessment due to later-than-expected site activation.
- Company believes positive ReCePI trial data could support broader indication in a future EU CE Mark submission.